Methods, systems, and devices for deploying an embolic protection filter

ABSTRACT

A filter device is adapted to function as a guidewire, an exchange guidewire, and provide embolic protection during a procedure. The filter device includes a filter assembly that is either integral with or coupled to a guide member. The filter assembly includes a plurality of struts that expand outwardly to deploy a filter that collects or captures material flowing along the blood vessel within which the filter device is deployed. The plurality of struts are constrained by a restraining member or mechanism that prevents the plurality of struts from expanding or extending outwardly to deploy the filter. Cooperating with the restraining member or mechanism is an actuating assembly that is adapted to release the restraining member or mechanism and enable the filter to be deployed from the guide member. A capture catheter is cooperates with the filter device and substantially surrounds the filter during removal of the filter device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 10/186,292, filed Jun. 28, 2002, which claimspriority to U.S. Provisional Patent Application Ser. No. 60/302,417,filed Jul. 2, 2001, U.S. Provisional Patent Application Ser. No.60/345,333, filed Nov. 9, 2001, U.S. Provisional Patent Application Ser.No. 60/347,500, filed Jan. 11, 2002 and U.S. Provisional PatentApplication Ser. No. 60/341,092, filed Dec. 12, 2001, the disclosures ofwhich are herein incorporated by this reference.

Additionally, this patent application incorporates by reference thedisclosure of co-pending patent applications entitled “Methods, Systems,and Devices for Providing Embolic Protection and Removing EmbolicMaterial,” U.S. patent application Ser. No. 10/186,275, “Methods,Systems, and Devices for Providing Embolic Protection,” U.S. patentapplication Ser. No. 10/186,304, and “Methods, Systems, and Devices forDeploying a Filter from a Filter Device,” U.S. patent application Ser.No. 10/186,255.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention relates generally to the field of percutaneousmedical filters, and more specifically, to vascular filter devices thatare configured for percutaneous insertion into a blood vessel of apatient.

2. The Relevant Technology

Human blood vessels often become occluded or blocked by plaque, thrombi,other deposits, or material that reduce the blood carrying capacity ofthe vessel. Should the blockage occur at a critical place in thecirculatory system, serious and permanent injury, and even death, canoccur. To prevent this, some form of medical intervention is usuallyperformed when significant occlusion is detected.

Several procedures are now used to open these stenosed or occluded bloodvessels in a patient caused by the deposit of plaque or other materialon the walls of the blood vessels. Angioplasty, for example, is a widelyknown procedure wherein an inflatable balloon is introduced into theoccluded region. The balloon is inflated, dilating the occlusion, andthereby increasing the intraluminal diameter.

Another procedure is atherectomy. During atherectomy, a catheter isinserted into a narrowed artery to remove the matter occluding ornarrowing the artery, i.e., fatty material. The catheter includes arotating blade or cutter disposed in the tip thereof. Also located atthe tip are an aperture and a balloon disposed on the opposite side ofthe catheter tip from the aperture. As the tip is placed in closeproximity to the fatty material, the balloon is inflated to force theaperture into contact with the fatty material. When the blade isrotated, portions of the fatty material are shaved off and retainedwithin the interior lumen of the catheter. This process is repeateduntil a sufficient amount of fatty material is removed and substantiallynormal blood flow is resumed.

In another procedure, stenosis within arteries and other blood vesselsis treated by permanently or temporarily introducing a stent into thestenosed region to open the lumen of the vessel. The stent typicallycomprises a substantially cylindrical tube or mesh sleeve made from suchmaterials as stainless steel or nitinol. The design of the materialpermits the diameter of the stent to be radially expanded, while stillproviding sufficient rigidity such that the stent maintains its shapeonce it has been enlarged to a desired size.

Unfortunately, such percutaneous interventional procedures, i.e.,angioplasty, atherectomy, and stenting, often dislodge material from thevessel walls. This dislodged material can enter the bloodstream, and maybe large enough to occlude smaller downstream vessels, potentiallyblocking blood flow to tissue. The resulting ischemia poses a seriousthreat to the health or life of a patient if the blockage occurs incritical tissue, such as the heart, lungs, kidneys, or brain, resultingin a stroke or infarction.

In general, existing devices and technology have a number ofdisadvantages including high profile, difficulty using multiple partsand components that result in an involved procedure, manufacturingcomplexity, and complex operation of the device or system.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention provide systems, methods, anddevices for overcoming the above-referenced problems. More specifically,embodiments of the present invention include filter devices that havesmall, low, or no profiles, few parts and components, and are simple tomanufacture and use. Consequently, embodiments of the present inventionare able to be easily inserted into a patient, be steerable through thetortuous anatomy of a patient, provide filtering capabilities, have asufficiently low profile to provide exchange capability so other medicaldevices can be advanced along the filter device, and be capable ofremoving the captured material without allowing such material to escapeduring filter retrieval.

According to one aspect of one embodiment of present invention, anillustrative embodiment of the present invention includes a vascularfilter device. This device includes a guide member, such as a guidewireor hypo-tube having a lumen that extends from a distal end toward aproximal end thereof. Disposed within the lumen are one or moreactuating members and a filter assembly. The one or more actuatingmembers are coupled to an actuating mechanism at the proximal end of theguide member and are configured to deploy the filter assembly during aprocedure, such as through movement of one or more actuating members.

The filter assembly includes a filter and a plurality of radiallyspaced-apart struts connected to a peripheral edge of a proximal end ofthe filter. The struts expand outwardly upon being deployed from thelumen of the guide member to place the peripheral edge of the proximalend of the filter adjacent to the wall of the vessel.

The filter includes a plurality of pores or holes that are so sized tocapture material that may become detached during the procedure. Theproximal end of the filter is configured to be constrained against theblood vessel within which the filter is disposed, while the distal end,in one embodiment, is configured to “float” within the blood flowingthrough the blood vessel and change shape to collect material andmaintain the flow of blood through the vessel.

In one embodiment of the present invention, the filter device includes anumber of radiopaque bands and/or markers affixed to a variety ofpositions on the device. These radiopaque bands and/or markers are oneexample of means for radiopacity, with various other means forradiopacity being known to those skilled in the art.

During use of the filter device of the present invention, blood flowwill cause the filter to assume a parachute-like configuration such thatmaterial is collected within the interior of the filter. To remove thefilter and the material, in one embodiment, the actuating member ismoved in the proximal direction so that the proximal end of the filtercooperates with the distal end of the lumen through the guide member.Upon positioning the proximal end of the filter, a capture catheter ismoved or advanced along the guide member until the cathetersubstantially encloses the filter. Following positioning of the capturecatheter, the catheter and guide member are removed from the patient.

According to another embodiment of the present invention, a guide memberincludes a plurality of struts disposed at the distal end of the guidemember. In one configuration, the distal end of the guide member isdivided into a plurality of struts, at least two of which are biased tomove outwardly. In another configuration, a strut assembly is coupled tothe distal end of the guide member, with the strut assembly includingone or more struts attached to the filter, while formed at a distal endof a third strut is a coil tip. This third strut is optionally biasedtoward the center of the lumen of the guide member. Before the filter isdeployed, the filter is folded about the distal end of the guide member,folded about one or more of the plurality of struts, and/or ispositioned within the lumen of the guide member.

To maintain the struts in the closed position, i.e., not extendingoutwardly from the remaining body of the guide member, a retainingmember or mechanism cooperates with the guide member and/or struts andapplies a restraining force to one or more of the struts. By moving theguide member relative to the restraining member, or vice versa, thedistal ends of two or more of the biased struts are allowed to moveoutwardly to deploy the filter, i.e., the restraining force is released.

In another configuration, the restraining member or mechanism surroundsa tip of the guide member, including the struts and a part of the guidemember. This restraining member or mechanism can be attached to thestruts and is configured to apply a restraining force to the one or morestruts. In one configuration, the restraining member or mechanism isconfigured to separate into a number of different sections to allow thedistal ends of two or more of the biased struts to move outwardly todeploy the filter. In another embodiment, the restraining member ormechanism includes two or more actuating members that are attached to alocation just proximal to the proximal end of each strut. The two ormore actuating members extend to the distal end of the guide member,pass through apertures in the distal end of the restraining member ormechanism, and terminate within the lumen of the guide member afterpassing through holes formed in the guide member proximal to theproximal end of each strut.

To actuate the filter device, an actuating assembly at the proximal endof the guide member draws the actuating members in the proximaldirection. Since one end of the actuating member is located at theproximal end of the restraining member or mechanism, whether formingpart of the restraining member or mechanism, attached to the restrainingmember or mechanism, or attached to the guide member, pulling theactuating member in the proximal direction causes the actuating memberto preferentially separate the restraining member or mechanism, therebyreleasing the strut.

In another configuration, the restraining member or mechanism includes aplurality of apertures formed therein. The restraining member ormechanism has a first portion and a second portion with one or more ofthe plurality of apertures formed therein. The restraining member ormechanism further includes a securing member that passes through one ormore of the plurality apertures to cause the first portion to bereleasably connected to the second portion. The securing member passesthrough an aperture in the guide member and/or a strut assembly to passinto the end of the guide member and extend toward the proximal end.Upon moving the securing member in a proximal direction using one of avariety of different actuating mechanisms, a distal end of the securingmember is removed from the apertures and the first and second bothportions of the restraining member or mechanism. In this manner, theforce applied to the struts to maintain a closed configuration, wherethe struts are retained or prevented from extending outwardly, isreleased from the struts, enabling them to deploy the filter.

In still another configuration, the restraining member or mechanismincludes a securing member that is “sewn” through portions of therestraining member. In a similar manner to the configuration discussedabove, the securing member can be removed from cooperating with therestraining member or mechanism to allow the struts to extend outwardlyand deploy the filter.

In still another configuration, the restraining member or mechanismincludes a plurality of channels. These channels are formed on bothfirst and second ends of the filter in an offset configuration. Thesecuring member can pass through one or more of the channels formed inthe first side and the second side to maintain the first side incooperative engagement with the second side. In this manner, therestraining member or mechanism applies a restraining force to the oneor more struts and prevents them from extending outwardly. Upon movingthe securing member in a proximal direction, a distal end of thesecuring member is removed from within the channels formed in the firstside and second side, thereby releasing the restraining force applied bythe restraining member or mechanism against the one or more struts.

In still another configuration, the restraining member or mechanism hasthe form of a sleeve that is adapted with one or more hoops formedtherein. The wire forms a channel by maintaining a first set of hoopsand second set of hoops in engagement using a securing member. Byremoving the securing member from engaging within one or more of thehoops, the first side and second side of the restraining member ormechanism can disengage with one another and release the restrainingforce that was applied to the one or more struts. In this manner, thestruts are able to deploy the filter.

In yet another configuration, the restraining member or mechanism iscombined with the one or more struts of the filter device. In such aconfiguration, two or more of the struts include tubular members adaptedto receive a securing member. As the struts are brought towards eachother, the lumens of the tubular members become aligned so that thesecuring member can pass therethrough to prevent the struts fromextending outwardly or otherwise maintain the struts together or inclose proximity one to another.

In still another configuration, the restraining member or mechanism iscombined with the filter of the filter device. In this configuration,the filter includes at least one flap that is adapted to extend throughthe gap disposed between two struts. The flap(s) can be wrapped aroundthe struts and secured to prevent the struts from extending outwardly.

These and other objects and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 illustrates an exemplary filter device according to oneembodiment of the present invention.

FIG. 2 illustrates an exploded perspective view of an exemplary tip ofthe filter device of FIG. 1.

FIG. 3 illustrates a cross-sectional side view of the exemplary tip ofthe filter device of FIG. 2.

FIGS. 4A-4I illustrates various cross-sectional side views of differentexemplary configurations or embodiments of the tip of the filter deviceof FIG. 2.

FIG. 5 illustrates a cross-sectional side view of the tip of the filterdevice of FIG. 2 with exemplary actuating member and filter assembly ina closed position.

FIG. 6 a illustrates a cross-sectional side view of the tip of thefilter device of FIG. 2 with exemplary actuating member and filterassembly in an actuated position.

FIG. 6 b illustrates one or more pores of the filter of the filterdevice of the present invention.

FIG. 7 illustrates a cross-sectional side view of the tip of the filterdevice of FIG. 2 with exemplary actuating member and filter assembly inan actuated position and a portion of the filter filled with material.

FIG. 8 illustrates a cross-sectional side view of the tip of the filterdevice of FIG. 2 with exemplary actuating member and filter assembly ina retracted position.

FIG. 9 illustrates a cross-sectional side view of an exemplary actuatingassembly of the filter device of FIG. 2.

FIG. 10 illustrates a perspective view of one exemplary capture catheteradapted for use with the filter device of the present invention.

FIG. 11 illustrates a cross-sectional side view of the actuating memberand filter assembly in a retracted position with the capture catheter inposition surrounding the filter of the filter device of FIG. 2.

FIG. 12 illustrates a flow diagram of an exemplary method for using thefilter device of FIG. 2.

FIG. 13 illustrates a portion of the vasculature of an individual withinwhich the filter device of FIG. 2 can be inserted.

FIG. 14 illustrates a lesion formed in the interior carotid artery ofthe individual of FIG. 13.

FIG. 15 illustrates one embodiment of the filter device of FIG. 2deployed in the interior carotid artery distal of the lesion of FIG. 14.

FIG. 16 illustrates one embodiment of the filter device of FIG. 2deployed in the interior carotid artery distal of the lesion of FIG. 14and a pre-dilation balloon.

FIG. 17 illustrates one embodiment of the filter device of FIG. 2deployed in the interior carotid artery distal of the lesion of FIG. 14and a stent located about the lesion.

FIG. 18 illustrates a partial cross-sectional side view of anotherembodiment of the filter device of the present invention.

FIG. 19 illustrates a cross-sectional side view of another exemplaryactuating assembly of the filter device according to the presentinvention.

FIG. 20 illustrates a partial cross-sectional view of yet anotherembodiment of the filter device of the present invention.

FIG. 21 illustrates a side view of a tip of the filter device of FIG.20.

FIG. 22 illustrates a side view of the embodiment of FIG. 20 with thefilter deployed.

FIG. 23 illustrates a side view of yet another embodiment of a filterdevice with a restraining member coupled to the filter device accordingto another aspect of the present invention.

FIG. 24 illustrates a side view of the embodiment of FIG. 23 with thefilter deployed.

FIG. 25 illustrates a cross-sectional side view of another exemplaryactuating assembly of the filter device according to the presentinvention.

FIG. 26 illustrates a perspective view of another embodiment of a filterdevice with a restraining member coupled to the filter device accordingto another aspect of the present invention.

FIG. 27 illustrates a perspective view of the restraining member of FIG.26 before becoming coupled to the filter device according to anotheraspect of the present invention.

FIG. 28 illustrates a perspective view of the restraining member of FIG.26 before becoming coupled to the filter device according to anotheraspect of the present invention.

FIG. 29 illustrates a perspective view of another restraining member ofthe filter device according to another aspect of the present invention.

FIG. 30 illustrates a perspective view of another embodiment of a filterdevice with a restraining member coupled to the filter device accordingto another aspect of the present invention.

FIG. 31 illustrates a perspective view of the restraining member of FIG.30 before becoming coupled to the filter device according to anotheraspect of the present invention.

FIG. 32 illustrates a side view of the restraining member of FIG. 30before becoming coupled to the filter device according to another aspectof the present invention.

FIG. 33 illustrates a side view of the restraining member FIG. 30 partway through restraining the filter device according to another aspect ofthe present invention.

FIG. 34 illustrates a side view of the restraining member FIG. 30 as itrestrains the filter device according to another aspect of the presentinvention.

FIG. 35 illustrates a perspective view of another embodiment of a filterdevice with a restraining member coupled to the filter device accordingto another aspect of the present invention.

FIG. 36 illustrates a perspective view of another embodiment of a filterdevice with a restraining member coupled to the filter device accordingto another aspect of the present invention.

FIG. 37 illustrates a side view of the restraining member of FIG. 36before becoming coupled to the filter device according to another aspectof the present invention.

FIG. 38 illustrates a side view of the restraining member of FIG. 36before becoming coupled to the filter device according to another aspectof the present invention.

FIG. 39 illustrates perspective view of the restraining member FIG. 36as it restrains the filter device according to another aspect of thepresent invention.

FIG. 40 illustrates a perspective side view of another embodiment of afilter device with a restraining member coupled to the filter deviceaccording to another aspect of the present invention.

FIG. 41 illustrates a perspective side view of the restraining memberFIG. 40 as it restrains the filter device according to another aspect ofthe present invention.

FIG. 42 illustrates a side view of another embodiment of a filter deviceaccording to another aspect of the present invention.

FIG. 43 illustrates a side view of yet another embodiment of a filterdevice according to another aspect of the present invention.

FIG. 44 illustrates a perspective view of another embodiment of acapture catheter used with the filter device of the present invention.

FIG. 45 illustrates a perspective view of yet another embodiment of acapture catheter used with the filter device of the present invention.

FIG. 46 illustrates a perspective view of still another embodiment of acapture catheter used with the filter device of the present invention.

FIG. 47 illustrates a side view of the capture catheter of FIG. 46 as itbegins to capture the filter device of the present invention.

FIG. 48 illustrates a side view of the capture catheter of FIG. 46 as itcaptures the filter device of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention generally relates to percutaneous filter devices,systems, and methods of using the same. Embodiments of the presentinvention can be utilized in association with devices, systems, andmethods for inserting a filter device, such as but not limited to avascular filter device, within any blood vessel of a patient.

One or more of the embodiments of the filter devices of the presentinvention meet criteria for both guidewires and filter devices. Forinstance, it is preferable that a guidewire is steerable. Consequently,embodiments of the filter device of the present invention can beinsertable within any blood vessel of a patient, such as but not limitedto, coronary artery, carotid arteries, renal arteries, bypass grafts,superficial femoral artery, the arteries of the upper and lowerextremities, or cerebral vasculature, and manipulated and steered by aphysician to traverse the tortuous anatomy of the patient to a lesion orocclusion.

To assist the physician with the above-recited endeavor, one or moreembodiments of the filter device include a shapeable, soft, distal tip.In addition, the filter device is capable of translating rotationalmovement or force applied to the proximal end thereof substantiallyequally to the distal end. In other words, with the filter devicepositioned within a vessel of the patient, as a physician rotates theproximal end of the filter device, the distal end of the filter devicerotates substantially simultaneously with the movement of the proximalend. This is typically defined as having a one-to-one torqueability.

Further, the filter device of the present invention is kink resistantand is capable of receiving a variety of different coatings to improvelubricity, have anti-thrombogenic properties, and/or reduce plateletaggregation. These coatings can include, but are not limited to, ahydrophilic coating, a heparinized coating, Teflon, silicone, or othercoating known to those skilled in the art in light of the teachingcontained herein.

With respect to the filter of the filter device of the presentinvention, in one embodiment, the filter is configured to capturematerial of a variety of sizes and enable removal of the capturedmaterial. Therefore, filter pore sizes and shapes can be selected basedupon the size of material to be captured. The material can include butis not limited to, particulates, thrombi, any atherosclerosis or plaquematerial dislodged during a procedure, or other foreign material thatmay be introduced in to the vasculature of the patient.

Referring now to FIG. 1, depicted is one embodiment of a vascular filterdevice, designated by reference number 10, of the present invention. Asillustrated, filter device 10 includes a guide member 12 having a distalend 14 and a proximal end 16. Extending between distal end 14 andproximal end 16 of guide member 12 is a lumen 18 within which isdisposed an actuating member 40 and a filter assembly 42. Distal end 14of guide member 12 includes a tip 15 that is configured for percutaneousinsertion into a blood vessel of a patient, while proximal end 16 isconfigured with or couples to an actuating assembly 20.

In this configuration, filter device 10 is capable of being insertableinto any blood vessel of a patient or body and function as a guidewireor exchange wire for other medical components or devices, such as butnot limited to catheters, stents, balloons, atherectomy devices, orother components or devices that can be exchanged using a guidewire.Further, filter device 10 can be used to filter particulates, as will bedescribed in more detail hereinafter, thereby acting or providingembolic protection during a procedure.

Illustratively, the term “guide member” can refer to a member that iscompletely solid, such as a guidewire, a member that partially includesa lumen therein, or a member that includes a lumen extending from aproximal end to a distal end thereof, such as a hypo-tube. Consequently,the term “guide member” can include or encompass a guidewire or ahypo-tube that is configured to perform the functions described herein.

Guide member 12 can be fabricated from a variety of materials. Forexample, guide member 12 can be fabricated from Nitinol, steel, metals,metal alloys, composites, plastic, polymer, synthetic materials, orcombinations thereof. Further, guide member 12 can be covered with avariety of different coatings, such as but not limited to, coatings toimprove lubricity or having anti-thrombogenic properties, reduceplatelet aggregation, hydrophilic coatings, a heparinized coating,Teflon, silicone, or combinations thereof.

Illustratively, guide member 12 can have an outside diameter of betweenabout 0.010 inches to about 0.035 inches, between about 0.014 inches toabout 0.018 inches, or between about 0.010 inches to about 0.018 inches.In one configuration, the outside diameter of guide member 12 is about0.014 inches. Similarly, the diameter of lumen 18 can range from about0.004 inches to about 0.029 inches or between about 0.008 inches toabout 0.014 inches. In one configuration, the diameter of lumen 18 isabout 0.008 inches.

As illustrated in FIGS. 2 and 3, the exemplary distal end 14 of guidemember 12 has a step configuration, with a step portion 22 of guidemember 12 having a smaller diameter than other portions of guide member12. For ease of explanation, actuating member 40 and filter assembly 42have been excluded from FIGS. 2 and 3.

The step portion 22 can have a variety of different configurations solong as it is adapted to couple with other portions of filter device 10.For instance, step portion 22 can include multiple steps instead of asingle step as illustrated in FIG. 2. Consequently, distal end 14 ofguide member 12 could include a first step portion having a first outerdiameter smaller than the outer diameter of the remaining portion ofguide member 12 toward proximal end 16 thereof. Further, distal end 14of guide member 12 could include a second step portion having a smallerouter diameter than the first outer diameter of the first portion.

Attached to step portion 22 of guide member 12 is a sheath 24. Sheath 24has a lumen 30 that extends between a distal end 26 and a proximal end28 thereof. A portion of distal end 26 is substantially co-planar withdistal end 14 of guide member 12 when sheath 24 is connected to guidemember 12. Stated another way, a portion of distal end 14 of guidemember 12 and distal end 26 of sheath 24 are contained within a planethat is substantially perpendicular to the longitudinal axis of lumen 18of guide member 12 when sheath 24 is coupled, connected, or attached toguide member 12. Although this is the case in one embodiment of thepresent invention, one skilled in the art can identify various otherconfigurations where this need not be the case. For instance, in analternate configuration, distal ends 14 and 26 are not co-planar. Inanother configuration, portions of distal ends 14 and 26 are co-planar.In still another configuration, at least one of distal ends 14 and 26 isangularly orientated relative to the longitudinal axis of lumen 18 orlumen 30.

As illustrated in FIG. 3, distal end 26 of sheath 24, either alone or incombination with distal end 14 of guide member 12 is atraumatic. In thismanner, as filter device 10 is inserted within a blood vessel filterdevice 10 is able to slide along the interior surface of the bloodvessel and is prevented from catching upon protrusions, i.e., lesions,occlusions, stenosis, or the like, during a procedure. One skilled inthe art can identify a variety of different configurations of distalends 14 and/or 26 to perform such a desired function. For instance, thecurvature of distal end 14 of guide member 12 can be varied as long asthe curvature allows filter device 10 to slide along the interiorsurface of the blood vessel without catching upon protrusions; thecurvature can be based upon distal end 14 of guide member 12 and/or thedistal end of sheath 24.

Proximal end 28 of sheath 24 is configured to cooperate with a proximalend of step portion 22. Proximal end 28 of sheath 24 and the proximalend of step portion 22 are substantially parallel one to another uponcoupling, connecting, or attaching sheath 24 to step portion 22. Inanother configuration, the proximal end of step portion 22 can includeone or more raised portions within which one or more complementaryrecesses formed in proximal end 28 mate, or vice versa. In still anotherconfiguration, sheath 24 has a stepped configuration that allows mattingwith a complementary configured stepped proximal end of step portion 22,such as when step portion includes multiple steps. Various otherconfigurations are applicable to allow sheath 24 and the remainder ofguide member 12 to couple, connect, or be attached one to another.

According to another aspect of one embodiment of the present invention,sheath 24 has an outside diameter substantially the same as the outerdiameter of guide member 12, while the diameter of lumen 30 issubstantially the same as the outer diameter of step portion 22.Consequently, when sheath 24 is coupled to guide member 12 at stepportion 22, guide member 12 has substantially the same outer diameteralong its length. In other configurations, sheath 24 has a smaller orlarger diameter than guide member 12.

As illustrated, sheath 24 is configured to friction fit to step portion22. Consequently, the inner diameter of sheath 24 is configured tosecurely mount to step portion 22 upon slidable engagement of sheath 24and step portion 22. In other configurations, sheath 24 can be affixedto step portion 22 with an adhesive, such as but not limited to, anymedical grade adhesive, UV curable adhesive, or other adhesive thatcause sheath 24 to securely connect to step portion 22. In still anotherconfiguration, sheath 24 can be press fit, soldered, mechanicalattached, or coupled to guide member 12 using any other mechanism thatcauses sheath 24 to be securely connected to step portion 22. In stillother configurations, sheath 24 and step portion 22 have a keyconfiguration where sheath 24 includes at least one key and step portion22 includes at least one key way to receive the at least one key, orvice versa.

In general, sheath 24 can be fabricated from a variety of differentmaterials and have a variety of different configurations. For example,sheath 24 can be fabricated from steel, titanium, platinum, metals,metal alloys, composites, plastics, polymers, synthetic materials, orcombinations thereof. Further, sheath 24 can include means forradiopacity. Additionally, sheath 24 can be fabricated from (i) aradiopaque substance, (ii) a non-radiopaque substance and coated with aradiopaque substance, or (iii) a non-radiopaque substance doped with aradiopaque substance. The radiopaque substances can include, but notlimited to, barium sulphate, bismuth subcarbonate, titanium dioxide,combinations thereof, or other radiopaque substances. In still anotherconfiguration, sheath 24 can include one or more markers that haveradiopaque characteristics. These markers can be fabricated from aradiopaque material, whether the material is radiopaque, anon-radiopaque material coated with a radiopaque material, or anon-radiopaque materials doped with a radiopaque material. Consequently,sheath 24 can include means for radiopacity, whether such means resultsfrom the materials forming sheath 24 or from attaching, coupling, orconnecting markers, bands, or other indicators having radiopaqueproperties or characteristics.

Disposed over sheath 24 and optionally a portion of guide member 12 iscover 32. Cover 32 is configured to seal and secure sheath 24 to guidemember 12. Consequently, cover 32 acts as a means for securing sheath 24to guide member 12. In one embodiment, cover 32 is a thin walled plasticheat shrink tubing or silicon tubing. In other configurations,interference fit or compression fit plastics, polymers, syntheticmaterials, or silicon can be used that need not be heat shrunk. Ingeneral, cover 32 can be a medical grade synthetic material.

According to another aspect of the present invention, distal end 14 ofguide member 12, distal end 26 of sheath 24, and/or the distal end ofcover 32 can be configured, collectively, to form a bullet nose or havea curved profile. This can be in addition to or alternatively from onlydistal end 14 of guide member 12 and/or distal end 26 of sheath 24 beingcurved or being atraumatic.

Collectively, distal end 14 of guide member 12, sheath 24, and cover 32form tip 15 of filter device 10. Although this is one configuration, oneskilled in the art can appreciate that tip 15 can be formed solely fromor any combination of guide member 12, sheath 24, and cover 32.

To provide flexibility to tip 15 of filter device 10, embodiments of thepresent invention may include one or more grooves 34 that extendentirely or partially through one or more of distal end 14 of guidemember 12, sheath 24, and cover 32, as illustrated in FIGS. 4A-4I. Theflexibility of tip 15 allows a physician or clinician to shape the tipand enable the guide member to be steered during a procedure.Consequently, the tip may maintain a level of resiliency so that acurvature defined by the physician or clinician is maintained duringmovement of the guide member through the tortuous anatomy of a patient.

The term “groove” includes one or more cuts or slits that partially orcompletely extend through a portion of filter device 10, optionallyincluding the sleeve and the securing member. Further, the term “groove”includes one or more cuts or slits that partially or completelysurrounds a portion of filter device 10, whether or not such one or morecuts or slits extend completely or partially through one or more of theguide member, the sleeve, or the securing member.

Each groove 34 can have a variety of different configurations, such asbut not limited to straight, helical, geometric, or combinationsthereof. For instance, a single groove 34 can extend around all or aportion of tip 15 and optionally extend into the remainder of filterdevice 10. Further, any number of grooves 34 can be included in tip 15of filter device 10 depending upon the degree of flexibility needed fora procedure. For example, the more grooves 34 included in tip 15 offilter device 10, the greater the flexibility. Similarly, the depth ofeach groove 34 can vary depending upon the flexibility desired. Forinstance, the deeper grooves 34 the greater the flexibility of tip 15 offilter device 10. Similarly, difference in the configuration of eachgroove 34 can affect the flexibility of tip 15 of filter device 10. Forinstance, the steeper the sides of grooves 34, the less flexibility oftip 15.

As illustrated in FIGS. 4A-4I, grooves 34 can be disposed along thelongitudinal length of tip 15 of filter device 10 equally, gradually,continuously, periodically, or combinations thereof. For instance, asshown in FIG. 4A, tip 15 includes a single helical groove 34 that has anequal pitch along the length of tip 15, while FIG. 4B depicts a singlehelical groove 34 that has a gradually increasing pitch along the lengthof tip 15. Although not shown, it can be understood that tip 15 caninclude a single helical groove 34 that has a gradually decreasing pitchalong the length of tip 15 from the proximal end to the distal endthereof.

As shown in FIG. 4C, tip 15 can have a plurality of individual grooves34 disposed along the length of tip 15. It can be understood that eachgroove 34 need not encircle tip 15 of guide member 12; rather, eachgroove 34 can partially encircle tip 15 of guide member 12, as depictedillustratively in FIG. 4D.

FIG. 4E depicts a configuration of tip 15 where groupings of grooves 34,whether straight, helical, or geometric, are disposed at differentportions of tip 15.

FIG. 4F depicts a configuration where grooves 34 are large and haveshallow sides, i.e., the angle between the axis of the groove thatpasses through the apex of the groove and the side of the groove islarge. In the alternative, each groove 34 can be small and have steepsides, i.e., the angle between the axis of the groove that passesthrough the apex of the groove and the side of the groove is small.

FIG. 4G illustrates a configuration of tip 15 of filter device 10 wherethe pitch between adjacent grooves is increasing from the proximal endto the distal end of tip 15 and the depth of each groove 34 varies,i.e., each groove 34 need not extend the entire depth of tip 15 offilter device 10.

FIG. 4H illustrates a configuration of tip 15 of filter device 10wherein grooves 34 are straight and extend into lumen 18, while FIG. 41illustrates a configuration where grooves 34 are helical and extend fromthe exterior of tip 15 to lumen 18.

The above described configurations of the grooves with tip 15 of filterdevice 10 are only illustrative and should not be considered as limitingthe applicability of other configurations as known by one skilled in theart in light of the teaching contained herein. For instance, grooves 34can pass through securing member 32, sleeve 24, and terminate in guidemember 12, can pass through sleeve 24 and terminate in guide member 12,be contained solely in guide member 12, combinations thereof, or thelike.

Generally, grooves 34 can be formed in tip 15 of filter device 10 usinga variety of different techniques, such as but not limited to,micro-machining, grinding, etching, laser cutting, abrasive water jet,electrical discharge machine, or the like. Further, grooves 34 can havea pitch of between about 0.015 inches to about 0.100 inches, from about0.020 inches to about 0.060 inches, or from about 0.025 inches to about0.050 inches.

Referring now to FIG. 5, depicted is a partial cross-sectional view of alumen 18 of guide member 12. Disposed within lumen 18 of guide member 12are an actuating member 40 and a filter assembly 42. Actuating member 40forms part of actuating assembly 20 and is adapted to deploy andpartially or completely retract filter assembly 42. Additionally,actuating member 40 provides structural support to filter device 10 andassists with preventing kinking of filter device 10.

The actuating member 40 extends toward a proximal end 16 of filterdevice 10. As illustrated, the distal end of actuating member 40includes a head 44. Head 44 has a generally cylindrical form and isconfigured to create a seal between actuating member 40 and the interiorwalls of lumen 18. In other embodiments of the present invention, theremainder of actuating member 40 is configured to create a seal betweenactuating member 40 and the interior walls of lumen 18. Alternatively,actuating member 40 and head 44 are not configured to create a seal withthe interior walls of lumen 18, rather a separate seal, such as but notlimited to, one or more O-rings, quad-rings, V-rings, gaskets,combinations thereof or other structure capable of creating a seals ismounted to head 44 to create a seal between the interior wall of lumen18 and head 44.

The head 44 of actuating member 40 cooperates or engages with filterassembly 42 and forces filter assembly 42 from the distal end of lumen18 as actuating member 40 is moved during a procedure. By so doing, afilter 50 of filter assembly 42 is deployed to collect material.Further, head 44 can be moved within lumen 18 by actuating member 40 toretrieve filter assembly 42, thereby aiding with removal of thecollected material subsequent to a procedure or to allow forrepositioning of filter 50 of filter assembly 42. The head 44 andactuating member 40 can have various other configurations so long asactuating member 40 is capable of deploying and retrieving filterassembly 42. For instance, in another configuration, actuating member 40can be devoid of head 44 and be formed from a plurality of wires,strands, or members that are braided together, connected to, or formedas part of filter assembly 42.

Actuating member 40 and head 44 can be fabricated from a variety ofdifferent materials, such as but not limited to, stainless steel,tungsten, titanium, platinum, Nitinol, other metals, alloys thereof,composites, plastics, polymers, synthetic materials, or combinationsthereof.

Referring now to FIG. 6 a and 6 b, depicted is filter assembly 42 in adeployed position following movement of actuating member 40 in thedistal direction. As illustrated, filter assembly 42 includes filter 50and a plurality of radially spaced-apart struts 52 extending from filter50 to head 44 of actuating member 40. Filter 50 has a distal end 54separated from a proximal end 58 by an intermediate portion 56. Aperipheral edge of proximal end 58 is secured to struts 52 to form anopening 60 that allows material to flow into filter 50, while distal end54 is closed to prevent material from escaping or exiting from filter50.

Although in one configuration filter is hemispherical, it can beunderstood that filter 50 can be a variety of configurations, such asbut not limited to, hemispherical, conical, cylindrical, combinationsthereof, or any other configuration that allows for material to becollected therein, while the opening of the filter substantially extendsto the peripheral surface of the blood vessel within which the filter isdisposed. More generally, filter 50 can have any configuration so longas proximal end 58 has an opening that allows material to flow intofilter 50 and distal end 54 is closed to prevent material from escapingor exiting from filter 50.

Intermediate portion 56 and distal end 54 are free to float in the bloodflow or stream within the blood vessel, while proximal end 58 is in afixed relationship with actuating member 40 through struts 52. Byallowing intermediate portion 56 and distal end 54 of filter 50 tofloat, as filter collects material, such as illustrated in FIG. 7, thematerial creates drag on filter 50 so that the shape of filter 50changes, while maintaining substantially the same volume as whendeployed. Consequently, blood can continue to flow through portions ofintermediate portion 56 as distal end 54 continues to fill withmaterial, as indicated by arrows A and B in FIG. 7. In this manner,material can be collected as blood flow is maintained through filter 50.

Filter 50 can be fabricated from a variety of different materials, suchas but not limited to, a woven or braided plastic or metallic mesh, aperforated polymer film, a Nitinol mesh, combinations thereof, or othermaterial that is capable of capturing material within flowing blood,while allowing the blood to flow through the pores or apertures thereof.Generally, filter 50 can be fabricated from a variety of materials solong as filter 50 is capable of being packed within lumen 18, floatingin the blood flow or stream passing through the blood vessel withinwhich it is inserted, and is biocompatible.

Filter 50 can have a variety of differently sized pores 51 ranging fromabout 50 microns to about 200 microns, from about 60 microns to about180 microns, or from about 75 microns to about 150 microns. Forinstance, as illustrated in FIG. 6 b, pores 51 can have a variety ofdifferent configurations, such as but not limited to circular, oval,polygonal, combinations thereof or other configurations known to oneskilled in the art in light of the teaching contained herein. In oneconfiguration, therefore, filter 50 can includes pores that aredifferently sized and configured. Consequently, a major or minor axis ofeach pore can have a variety of different sizes ranging from about 50microns to about 200 microns, from about 60 microns to about 180microns, or from about 75 microns to about 150 microns. Generally, thepore size can vary as needed, so long as the pores are sized so that thepores do not compromise blood flow through the filter, i.e., preventblood flowing through the filter, and collect material that couldpotentially occlude smaller downstream vessels, potentially blockingblood flow to tissue or result in stroke or infarction.

In addition to the above, filter 50 can be coated with a hydrophiliccoating, a heparinized coating, Teflon, silicone, combinations thereof,or various other coatings as know or desired by one skilled in the artin light of the teaching contained herein.

Referring again to FIG. 6 a, connecting filter 50 to head 44, andoptionally directly to actuating member 40, are struts 52. Asillustrated, the distal ends of struts 52 are connected at radiallyspaced-apart locations about the peripheral edge of proximal end 58 offilter 50. The struts 52 attach to filter 50 on the exterior of filter50, on the interior of filter 50, along the edge of filter 50, throughfilter 50, or combinations of one or more of the above. The struts 52can be attached to filter 50 and/or actuating member 40 by medical gradeadhesives, such as but not limited to, ultra violet curable adhesives,acrylics, cyanoacrylates, solvent bonding, radio frequency or ultrasonicbonding, or some other manner to securely connect the distal end of oneor more struts 52 to filter 50. Alternatively, struts 52 can bethermally bonded to filter 50 and/or actuating member 40, such as whenstruts 52 are fabricated from a material allowing such thermal bonding.In another configuration, struts 52 are woven into filter 50 or aredistally formed with hooks or loops that are can be used to attachstruts 52 to filter 50. In still another configuration, struts 52 can belengthened strands of filter 50 that extend from filter 50 to actuatingmember 40. In still another configuration, struts 52 are extensions orstrands of actuating member 40, such as when actuating member 40 is abraided wire, a slit tube, or other member that is capable of performingthe functions described herein with respect to actuating member 40. Instill another configuration, struts 52 are extensions of filter 50 thatextend to head 44 and connect thereto.

As illustrated, each strut 52 is formed from Nitinol, stainless steel,metals, alloys, composites, plastics, polymers, synthetic materials,combinations thereof, or other materials that allow struts to performone or more of the functions described herein. Each strut 52 can have agenerally curved distal portion 62 and may be biased to extend radiallyoutward when filter 52 is to be deployed. In this manner, distal portion62 is in close proximity to the wall of the blood vessel within whichfilter device 10 is inserted when deployed. The struts 52 extend theedge of proximal end 58 of filter 50 into contact with the wall of theblood vessel. By so doing, the proximal end 58 of filter 50 can contacta substantial portion of the wall of the blood vessel and accommodatefor variations in the profile of the wall.

Although, reference is made to the edge of proximal end 58 contactingthe blood vessel, other configurations of the present invention locatethe edge of proximal end 58 adjacent to, in close proximity to,juxtaposed, or contiguous with the wall of the blood vessel. This can bethe case, so long as material can be captured through opening 60 andmaterial is not captured between the outer surface of filter 50 and thewall of the blood vessel within which filter device 10 is inserted.

Referring now to FIG. 8, depicted is filter 50 in the captured orretrieved position. When actuating member 40 is moved in the proximaldirection, opening 60 of filter 50 is drawn toward distal end 14 ofguide member 12. As actuating member 40 is moved in the proximaldirection, the interior wall of lumen 18 forces struts 52 inwardly.Simultaneously, distal end 62 of each strut 52 moves inwardly to closeopening 60. This simultaneous motion prevents material trapped withinthe interior of filter 50 from escaping. Opening 60 can alternatively besubstantially completely closed following the initial movement ofactuator member 40 in the proximal direction. In still anotherconfiguration, opening 60 can be partially closed as actuator member 40is moved in the proximal direction and gradually becomes substantiallycompletely closed upon a substantial portion of struts 52 beingretracted into lumen 18 of filter device 10. In still anotherconfiguration, opening 60 can be substantially completely closed upon aportion of struts 52 being retracted into lumen 18 of filter device 10.

To move actuating member 40 in the proximal direction and/or distaldirection filter device 10 includes an actuating assembly 20. Theactuating assembly 20 can be integrated with guide member 12 and/orseparate therefrom. With reference to FIG. 9, depicted in anillustrative configuration of actuating assembly 20.

Referring now to FIG. 9, depicted is an exemplary embodiment of anactuating assembly 20 that can be used to manipulate actuating member40. Through operating actuating assembly 20, filter assembly 42 (FIG. 5)can be deployed and retrieved.

As illustrated, actuating assembly 20 includes an actuating element 70and actuator member 40. Actuating element 70 includes a distal end 74that is configured to cooperate with guide member 12, while a proximalend 76 of actuating element 70 is attached to proximal end 16 of guidemember 12. The distal end 74 has a step configuration and includesindentations 78 that are configured to cooperate with complementaryprotrusions 80 formed in guide member 12. As actuating element 70 ismoved in the distal direction, indentations 78 and protrusions 80 mateto position actuating element 70 in a desired location relative toproximal end 16 of guide member 12, thereby positioning filter assembly42 in a selected position, such as in the retracted position illustratedin FIG. 9.

As actuating element 70 is continually moved in the distal direction,distal end 74 meets a wall 82 formed in guide member 12 that preventsfurther movement in the distal direction. Through this configuration,actuating element 70 is prevented from excessive longitudinaldisplacement in the distal direction. This stopping of the longitudinaldisplacement of actuating element 70 indicates that filter assembly 42is deployed.

Although reference is made to one manner to indicate the particularlocation filter assembly 42, one skilled in the art can identify avariety of different manners. For instance, a plurality of indentationsand/or protrusions can be included within actuating element 70 and guidemember 12 to control the distance which actuating element 70 andconsequently filter assembly 42 is moved. In another configuration, awall formed in actuating element 70 mates with the distal end of guidemember 12 to prevent excessive longitudinal displacement in the distaldirection. In still another configuration, a combination of walls inactuating element 70 and guide member 12 can be used. In still anotherconfiguration, distal end 76 of actuating element 70 is tapered andcooperates with a taper formed in proximal end 16 of guide member 12.The complementary tapers control the longitudinal displacement ofactuating element 70 relative to proximal end 16 of guide member 12. Instill other configurations, a combination of indentations, protrusions,walls, or tapers can be used. Various other manners are known to controlthe distance traveled by actuator element 70 while indicating theposition of filter assembly 42.

To remove filter device 10 from within the patient, embodiments of thepresent invention provide a capture catheter 90, as shown in FIG. 10.Capture catheter 90 is adapted to enclose filter 50 to prevent filterfrom tearing or catching on stents, grafts, other implants, guidemembers, catheters, sheaths, or other protrusions that may beencountered as filter 50 is removed from the patient.

As illustrated in FIG. 10, capture catheter 90 has a generally elongateform having a lumen 92 extending from a distal end 94 to a proximal end96 thereof. Disposed at distal end 94 is at least one radiopaque markeror band 100 that aids a physician or clinician in placing capturecatheter 90 in the desired location relative to filter 50, asillustrated in FIG. 11. Through viewing the insertion of capturecatheter 90 through a fluoroscope, a physician or clinician can placedistal end 94 to surround filter 50.

The lumen 92 of capture catheter 90 is adapted to receive filter 50 andsubstantially completely enclose filter 50. The inside diameter of lumen92 is configured to engage with struts 52 when they are in the openconfiguration, i.e., filter 50 is in the deployed position, and pushstruts 52 radially together to close opening 60. Through thisconfiguration, opening 60 is closed before distal end 94 of capturecatheter 90 contacts filter 50 and the engagement of capture catheter 90with filter 50 does not cause embolic material to escape from withinfilter 50.

As capture catheter 90 is advanced over filter 50, it is compressed intolumen 92 of capture catheter 90. To limit the amount of compression ofthe embolic material within filter 50, a section of lumen 92 which orthat optionally has greater elasticity than the remainder of capturecatheter 90, the border of this section being represented by dottedlines in FIG. 10. By so doing, this portion of capture catheter 90 canexpand around filter 50 and any captured embolic material.

Capture catheter 90 can have various configurations and be fabricatedfrom a variety of different materials. For example, capture catheter 90can be fabricated from metals, alloys, plastics, polymers, syntheticmaterials, composites, or other medical grade materials. Further,capture catheter 90 can be kink resistant, biocompatible, radiopaque, inwhole or in part, and capable of being exchanged over guide member 12.Additionally, the elasticity of capture catheter 90 can be constantalong its length, variable along its length, constant along a portionand variable along another portion of capture catheter 90, orcombinations thereof.

As illustrated in FIG. 10, disposed at proximal end 96 of capturecatheter 90 is a locking mechanism 98. The locking mechanism 98 engageswith the proximal end of guide member 12 to securely capture guidemember 12 when distal end 94 partially or completely surrounds filter 50(FIG. 11). In one configuration, locking mechanism 98 is an annularclamp that can be rotated to clamp a proximal end of guide member 12. Inanother configuration, locking mechanism 98 can be a rotating hemostatisvalve through which is disposed the proximal end of guide member 12. Instill another configuration, locking mechanism 98 can be a lockingjaw-set, such as a mechanical collett. Each of these locking mechanismscan be configured in a variety of different manners and fabricated froma variety of different materials as known to those skilled in the art.For instance, the locking mechanism can be fabricated from plastics,polymers, metals, synthetic materials, alloys, or various othermaterials.

According to another aspect of the present invention, filter device 10is generally used with a fluoroscope that enables a physician to viewthe insertion of filter device 10 through the tortuous anatomy of apatient. To enable filter device 10 to be visible to the physician,filter device 10 includes radiopaque bands, markers, or other means forradiopacity that provide reference points for the physician. Withreference to FIG. 7, various locations are illustrated as beingradiopaque by reference letter R. As shown, tip 15 of filter device 10is radiopaque. More specifically, the most distal portion of distal end14 is radiopaque so that the physician knows the location of tip 15 offilter device 10.

The distal end of actuating member 40 is radiopaque so that thephysician knows whether filter assembly 42 is in the stored, deployed,or retrieved position, while distal end 54 of filter 50 includes aradiopaque marker that defines the most distal portion of filter device10. Similarly, capture catheter 90 can include radiopaque bands, othermarkers, or means for radiopacity to define the distal end thereof.

In addition to the distal ends of guide member 12, capture catheter 90,actuating member 40, and filter 50, embodiments of the present inventioninclude radiopaque markers or other means for radiopacity at thejunction of struts 52 and proximal end 58 of filter 50. In this manner,a physician can view the location of opening 60 during the procedure andverify that opening 60 is closed before the physician retrieves filterdevice 10 when the procedure is completed.

Although reference is made to placing radiopaque bands or markers atvarious locations on the components of filter device 10, one skilled inthe art can identify various other locations where radiopaque bands,markers, or other means for radiopacity are appropriate. Further,embodiments of the present invention need not include all discussedradiopaque bands or markers, but rather can include one or more of thedescribed radiopaque bands or markers as desired.

Following hereinafter is a discussion of an illustrative manner by whicha filter device of one embodiment of present invention is inserted intoa carotid artery. Although reference is made to the present inventionbeing inserted into a carotid artery, it can be understood by oneskilled in the art that different methods can by used to insert thefilter device of the present invention into any blood vessel within apatient.

With reference to FIGS. 12-17, initially, a small needle is used to gainfemoral access, as represented by block 110. This small hole issubsequently dilated until the hole is large enough to allow theinsertion of an introducer of appropriate size as known to one skilledin the art.

With reference to FIG. 13, it can be understood by one skilled in theart, that a variety of different access sites can be used. For example,the right subclavian artery 210, left subclavian artery 206, rightbrachial artery 218, left brachial artery 215, right femoral artery 225,left femoral artery 220, right radial artery and left radial arteries227, 228, or any other artery as by one skilled in the art can be usedto enter a patient's arterial circulation. Alternatively, as known byone skilled in the art, any other blood vessel selectable by thephysician can be chosen as an access site.

Referring now to FIGS. 12-17, following insertion of the introducer, aguidewire 230 is inserted into the femoral access site and steered,under fluoroscopy, to the desired location in the arterial system, justproximal to the lesion to be treated, as represented by block 112. Inthis illustrative example, the following discussion relates to stentingof a lesion in the internal carotid artery, as referenced by arrow D inFIG. 12 and illustrated in FIG. 13.

Guidewire 230 and guide catheter 232 are advanced together incrementallyuntil the distal tip of guidewire 230 is placed proximal to the lesion,as represented by block 114 and shown in FIG. 12. Upon placing guidecatheter 232, guidewire 230 is removed and filter device 10 is advancedthrough guide catheter 232, as represented by block 116 and illustratedin FIG. 14.

The filter device 10 is carefully advanced through the lesion to a pointdistal to the lesion and subsequently acts as an exchange guidewire witha filter attached. Alternatively, filter device 10 can function as guidemember 230 so that a physician need not exchange filter device 10 forguidewire 230. In such a configuration, the steps of placing the filterdevice and accessing the lesion can be performed simultaneously. Thisparticular configuration is useful because it limited the number ofexchanges performed by the physician and consequently accelerates theperformance of the procedure.

Once in position, moving actuating member 40 distally actuates filterdevice 10 and deploys filter 50, as represented by block 118 and shownin dotted lines in FIG. 15. In this manner, filter assembly 42 isdeployed from lumen 18 of guide member 12 and struts 52 expand to secureproximal end 58 of filter against the wall of the vessel, as shown inFIG. 6 a. Alternatively, when struts 52 are formed from the samematerial as filter 50, the flow of blood through the vessel causesproximal end 58 to become secured against the wall of the vessel.Consequently, in either case, the blood flowing through the lesionsubsequently flows through filter 50.

Next, a stent is placed over the lesion, as represented by block 120.This may be preceded by advancing a pre-dilation balloon 234, such as arelatively long, high-pressure balloon, over filter device 10, shown indotted lines, until balloon 234 is within the lesion. Next, balloon 234is inflated to dilate the lesion, as illustrated in FIG. 16, and thendeflated and removed from the patient. Then a stent delivery system isadvanced over guide member 12 until a stent 236, shown in dotted linesin FIG. 17, is within the lesion. The stent delivery system deploysstent 236, which then expands to fit the interior of the lesion withinthe artery. Once stent 236 is thus deployed, the stent delivery systemis then removed.

To secure stent 236 in place, a post-dilation balloon, having a similarconfiguration to the pre-dilation balloon, is advanced over filterdevice 10 until the balloon is within stent 236. Subsequently, thepost-dilation balloon is inflated to a pressure and held at the desiredpressure for a period selected by the physician. The maintenance of theballoon at such a pressure for this period causes stent 236 to beimbedded into the inner wall of the vessel. Following imbedding stent236 into the inner wall of the vessel, the balloon is deflated andremoved.

To complete the procedure, the devices within the patient and puncturedvessel and tissue are closed. With respect to filter device 10, lockingmechanism 20 is activated to cause actuating member 40 to move in theproximal direction. The actuating member 40 draws struts 52 within lumen18 of guide member 12, thereby causing proximal end 58 of filter 50 tobe retained within lumen 18, as illustrated in FIG. 8 and represented byblock 122 in FIG. 12. In another configuration, activating actuatingmember 40 causes proximal end 58 of filter 50 to contact distal end 26of guide member 12, while remaining external from lumen 18. In eithercase, the material captured within filter 50 are enclosed and preventedfrom escaping during removal of filter device 10. By locating proximalend 58 of filter 50 within lumen 18 or in contact distal end 26 of guidemember 12, filter device 10 securely encloses the material with asufficiently low force to prevent escape of any material but not causematerial to be extruded through the holes of filter 50.

Once filter 50 is in the retracted position, capture catheter 70 isadvanced over guide member 12 until the capture catheter encloses filterdevice 10, as illustrated in FIG. 11. This capture catheter isoptionally locked in place with respect to guide member 12 and thefilter system, including filter device 10. Subsequently, the capturecatheter 70 and the filter device 10 are removed from the patient, asrepresented by block 124. To complete the procedure, all remainingdevices are removed from the patient and the vessel puncture is closed.

The previously described embodiment of a filter device of the presentinvention is only one illustrative embodiment of the filter device. Thefollowing discussion provides various other configurations of variousalternate embodiments of the filter device, including the guide member,the capture catheter and various elements of components. The followingembodiments can be used in a similar manner to filter device 10 inperforming the above-discussed method to insert the filter device into acarotid artery or some other body lumen. Further, the applicability ofthe features and functions discussed with respect to the previouslydiscussed embodiment of the present invention are applicable to the tothe following embodiments.

Referring now to FIG. 18 is another configuration or embodiment of thefilter assembly and actuating assembly. As depicted in FIG. 18, a filterdevice 310 includes a guide member 312 having a distal end 314 and alumen 318 extending from distal end 314 toward a proximal end (notshown). In this particular configuration, a sheath and cover areexcluded from guide member 312. In another configuration, however, asheath and cover can be included in a similar manner to guide member 12.

Disposed within lumen 318 are a filter assembly 342 and an actuator 340,with associated head 344. The filter assembly 342 includes a filter 350,which can be similar to other filters described herein, and a pluralityof struts 352 extending from filter 350 to actuator 340 or head 344.Each strut 152 includes a distal portion 362, a proximal portion 366,and an intermediate portion 364 disposed between distal portion 362 andproximal portion 366. The struts 352 attach to filter 350 on theexterior of filter 350, on the interior of filter 350, along the edge offilter 350, through filter 350, or combinations of one or more of theproceeding. To provide additional surface area to connect each strut 352to filter 30, each strut 352 can be configured so that distal portion362 has a cross-sectional dimension larger than intermediate portion364. Stated another way, distal portion 362 can have a larger surfacearea than intermediate portion 364. The large cross-sectional areaprovided by the cross-sectional dimension of distal portion 312 provideslarge area for bonding each strut 352 to filter 350. In thisconfiguration, a strong bond is created between each strut 352 andfilter 350.

Similarly, each strut 352 can be configured so that proximal portion 366has a cross-sectional dimension larger than intermediate portion 364,while optionally having a similar, larger, or smaller cross-sectionaldimension than distal portion 362. By having a large cross-sectionaldimension and hence large surface area, each strut 352 can be securelyconnected to actuating member 340 or head 342 which can be similar toother actuating members and heads described herein.

By varying the cross-sectional dimensions of distal portion 362,intermediate portion 364, and/or proximal portion 366, the degree ofbias exerted by each strut 352 to move distal portion 362 toward thewall of a blood vessel can be varied. The biasing force can also bechanged through optionally varying the length of each strut 352 and/orchanging the curvature of each strut 352.

Although reference is made herein to each strut 352 having theabove-referenced configurations, one skilled in the art can appreciatethat one or more of struts 352 can be configured as described above.Further, each strut 352 can optionally be configured differently so thateach strut 352 can have similar or dissimilar biasing forces compared toothers struts 352 of the same filter device. Through varying the biasingforces, the filter device can be used for a variety of differentprocedures or blood vessel configurations.

Struts 352 can be formed from Nitinol, stainless steel, metals, alloys,composites, plastics, polymers, synthetic materials, or combinationsthereof. Each strut 352 can have a generally curved distal portion 362,proximal portion 366, and/or intermediate portion 364.

Referring now to FIG. 19, illustrated is an alternate embodiment ofactuator assembly, designated by reference number 420. This particularembodiment of actuator 420 is capable of deploying and retrieving afilter assembly with use of a clamp assembly 472.

As illustrated, actuating assembly 420 includes an actuating element470, and an actuating member 440, each of which can be similar to otheractuating elements and actuating members described herein. Actuatingelement 470 includes a distal end 474 that is configured to cooperatewith guide member 412, which can be similar to the other guide membersdescribed herein, while a proximal end 476 of actuating element 470 isattached to proximal end of actuating member 440. The distal end 474 hasa step configuration and includes protrusions 478 that are configured tocooperate with complementary indentations 480 formed in guide member412. As actuating element 470 is moved in the distal direction, such asby a physician, clinician, or a device operated by the physician,clinician, or technician, protrusions 478 and indentations 480 mate toposition actuating element 470 in a desired location relative toproximal end 416 of guide member 412, thereby positioning filterassembly 442 in a selected position, such as in the retracted positionillustrated in FIG. 8.

As actuating element 470 is continually moved in the distal direction,distal end 474 meets a wall 482 formed in guide member 412 that preventsfurther movement in the distal direction. Through this configuration,actuating element 470 is prevented from excessive longitudinaldisplacement in the distal direction. This stopping of the longitudinaldisplacement of actuating element 470 indicates that filter assembly 442is deployed.

As illustrated, actuator element 470 engages with clamp assembly 472.The clamp assembly 472 includes two annular clamp sets 484 and 486.Clamp set 484 couples to actuator element 470, while clamp set 486couples to guide member 412. In this illustrative embodiment, clamp set484 is capable of being translated along the longitudinal axis of thefilter device, while clamp set 486 is fixed. Clamp set 484 can beconnected to a threaded screw, hydraulic rams, pneumatic rams, slidesystems, linear actuators, combinations thereof, or the like thatenables clamp set 484 to move in the proximal and distal directions. Forinstance, in one embodiment a threaded screw is rotatably attached toclamp set 486, with clamp set 484 mounted thereto. Upon rotating thethreaded screw, clamp set 484 advances along the threaded screw ineither the proximal or distal direction to open or retract the filterassembly (not shown) of the filter device.

Generally, clamp assembly 472 can include a variety of different clampsets, whether annular or opposed clamping jaws or clamp set, or the likeas known to one skilled in the art. Further, clamp assembly 472 can usepneumatics, hydraulics, electricity, combinations thereof, or the liketo move actuator element 470 and/or guide member 412.

Referring now to FIG. 20, another illustrative embodiment of the presentinvention is depicted. As shown, a guide member 512, which can besimilar to the other guide member described herein, has a distal end514, a proximal end 516, and a lumen 518 extending from distal end 514to proximal end 516. A tip 515 of guide member 512 includes a pluralityof struts 522, such as three or more struts. Each strut 522 can bebiased such that a distal end thereof is biased to move outwardly fromthe longitudinal axis of guide member 512.

At least one strut, designated by reference numeral 524, is biasedtoward the longitudinal axis of guide member 512, as shown in FIG. 21.Disposed upon strut portion 524, as more clearly seen in FIG. 20, is acoil tip 526 that is commonly used with guidewires. This coil tip 526,either alone or in combination with strut 524, may be configured toallow a physician or clinician to shape the same before insertion into abody lumen. In this manner, the physician or clinician is able toconfigure the tip with an appropriately shaped J that enables guidemember 512 to be guided through the tortuous anatomy of a patient. Thecoil tip 526 can be platinum, platinum alloys, radiopaque materials,metals, alloys, plastic, polymer, synthetic material, combinationsthereof, or other materials that provide an appropriate radiopaquesignature, while capable of being shaped, whether alone or incombination with strut 524, by a physician or clinician.

Attached to the distal ends of two or more of struts 522 is a filter550. As shown, filter 550 is disposed within lumen 518 of guide member512. In alternate embodiments, filter 550 can surround guide member 512or partially surround and partially be contained within lumen 518.Filter 550 can have a variety of different configuration such as thosedescribed with respect to the other filters described herein.

Filter 550 can be attached to guide member 512 via a variety ofdifferent techniques and methods as known to one skilled in the art. Forinstance, filter 550 can be attached through adhesives, solvent bonding,thermal bonding, mechanical connections, or some other manner that iscapable of securely connecting filter 550 to one or more of struts 522.In another configuration, a distal end of two or more struts 522 caninclude respective holes (not shown) through which strands of filter 550can be passed and attached to strut 522 to connect filter 550 to struts522. Alternately, the strands can be tied in a knot or folded back uponfilter 550 and woven into or affixed to filter 550.

To maintain struts 522 in the closed position, i.e., not extendingoutwardly from guide member 512, a catheter 540 surrounds guide member512. The catheter can extend completely or partially from the distal endto the proximal end of guide member 512. Illustratively, the cathetercan surround substantially only struts 522. The catheter 540 acts as arestraining member or mechanism that applies a force against the strutsto prevent the struts from extending outwardly. Catheter 540 can have alumen (not shown) that has an inside diameter that is sufficientlysimilar to the outside diameter of guide member 512 that struts 522 arerestrained from extending outwardly. Through moving guide member 512with respect to catheter 540, or vice versa, the distal ends of two ormore of struts 522 are allowed to move outwardly to deploy filter 550,as illustrated in FIG. 21 that depicts guide member 512 having twostruts 522. Retracting filter 550 and catheter 540 can be performed in asimilar manner to that described with respect to the other filterdevices discussed herein, such as but not limited to using a capturecatheter.

As mentioned above, the catheter can extend completely or partially thelength of the guide member. In another configuration, the catheter canbe replaced with a sleeve, a band, or other structure that partiallyextends toward the proximal end of the guide member from the distal end.These sleeves, bands, or other structures can be radiopaque or includeone or more radiopaque markers. Furthermore, these sleeves, bands, orother structures can be slidable relative to the guide member using anactuating member that is disposed on the exterior of the guide member,within the lumen of the guide member, or partially within the lumen andpartially on the exterior of the guide member. The actuator member canbe any of the actuator members described herein.

According to an alternate configuration of the present invention, afilter device 610 includes a guide member 612 with a plurality of struts622 disposed at a distal end 614 thereof. These struts 622 can bemaintained in the closed position using a sleeve 660, as illustrated inFIG. 22. The sleeve 660 acts as a restraining member or mechanism thatapplies a force against the struts to prevent the struts from extendingoutwardly.

Sleeve 660 surrounds struts 622, and a filter 650, which can be similarto other filters described herein, when filter 650 is located on anexterior surface of guide member 612. Disposed within sleeve 660 orbetween sleeve 660 and guide member 612 and/or filter 650 are one ormore actuating members or actuating members 654. These actuating members654 are attached to guide member 612 at a location just proximal to theproximal end of each struts 622, identified by letter E, extend distallyto the distal end of sleeve 660, and subsequently extend proximally onthe outside of sleeve 660 to terminate at an actuating element 670 of anactuating assembly 620 (FIG. 25) via one or more holes 656 and lumen618. Since one end of each actuating member 654 is located at theproximal end of sleeve 660, whether forming part of sleeve 660, attachedto sleeve 660, attached to guide member 612, or combinations thereof,pulling actuating member 654 in the proximal direction by actuatingelement 670 of actuating assembly 620 (FIG. 25) causes actuating member654 to preferentially separate sleeve 660 into one or more portions,thereby releasing struts 622, as illustrated in FIG. 24.

Stated another way, and with reference to FIG. 25, one or more ofactuating members 654 can cooperate with an actuating assembly 620 andconnect to actuating element 670, such as through soldering, adhesives,or other forms of attachment. The actuating element 670 can be moved inthe proximal direction until a stop member 672 formed in a proximal end616 of actuating element 670 engages with a stop member 674 in guidemember 612. During the movement from a distal end 676 of actuatingelement 670 cooperating with a surface 678 of guide member 612 to stopmember 672 engaging with stop member 674, actuating member 654 moves ina proximal direction to preferentially separate sleeve 660.

Sleeve 660 can be formed from a variety of different materials, so longas the material is sufficiently strong to secure struts 522, while beingconfigured to preferentially separate under the action of actuatingmember or actuating member 654. For example, sleeve 660 can befabricated from heat shrink synthetic material, including but notlimited to, low-density polyethylene (LDPE), polyethylene terphthalate(PET), Polytetrafluoroethylene (PTFE), fluorinated ethylene propylene(FEP), polyethylene (PE), polyurethane (PU) or silicone tubing.

Actuating members 654 can be formed from a variety of differentmaterials, so long as the material used is sufficiently strong to allowan actuating mechanism, such as those actuating mechanisms disclosedherein, to move actuating members or actuating member 654 proximallywithout breaking the same. For example, actuating members 654 can befabricated from plastics, polymers, metals, composites, alloys,synthetic materials, or combinations thereof.

Instead of using actuating members 654, embodiments of the presentinvention can employ various other manners to preferentially separatesleeve 660. For example, sleeve 660 can have dissolvable chemical bondswhich dissolve due to a chemical reaction with the fluid in the vesselwithin which the filter device is disposed, bonds that are brokenthrough applying resistive heating, ultrasonic or radio frequencyenergy, preferential regions or zones where the material has a weakerstrength than other regions or zones of the sleeve, or combinationsthereof.

Following is a discussion of other methods, devices, and systems forrestraining or constraining one or more struts attached to or integrallyformed as part of a guide member. The embodiments provide methods,devices, and systems for, applying a restraining force to one or morestruts and subsequently releasing the same to allow the struts to expandoutwardly.

Referring now to FIG. 26, depicted is a perspective view of oneembodiment of a restraining member or mechanism. The restraining memberor mechanism, is in the form of a sleeve 760 and associated securingmember 762, the combination of which is adapted to surround one or morestruts 752 of a guide member 712 and apply a restraining force againststruts 752 to maintain struts 752 in a closed configuration. The sleeve760 includes a first side 764 and a second side 766 with first andsecond sides 764, 766 being separated by an intermediate portion 768.The sleeve 760 surrounds guide member 712 in such a manner thatintermediate portion 768 surrounds guide member 712 so that portions ofintermediate portion 768 contacts with, are juxtaposed to, arecontiguous with, or are adjacent one to another. The securing member 762passes through such portions of intermediate portion 768 to securesleeve 760 upon guide member 712. To further aid with applying arestraining force against struts 752, first side 764 and second side 766are folded to attach to respective portions of outside surface of sleeve760.

The process of forming the restraining member or mechanism of FIG. 26 isillustrated in FIGS. 27 and 28. With reference first to FIG. 27, whichdepicts sleeve 760 in an open position before securing member 762 iscoupled thereto, sleeve 760 can be directly formed on guide member 712or can be formed on a separate tubular member and subsequently attachedor coupled to guide member 712. Sleeve 760 is illustrated as having agenerally polygonal configuration, however, one skilled in the art canappreciate that sleeve 760 can have various other configuration so longas it is capable of performing the functions described herein. In thisexemplary configuration, sleeve 760 is coupled directly to a guidemember 712. The first side 764 and second side 766 of sleeve 760 arewrapped around at least a portion of guide member 760, until a portionof intermediate portion 768 is in close proximity another portion ofintermediate portion 768. Alternatively, a first side 764 can becontacting, juxtaposed, contiguous, or adjacent to second side 766.

When the portions of intermediate portion 768 are in close proximity,securing member 762, or alternatively some other actuating member, isstitched through both sleeve 760 to couple the portions of intermediateportion 768, as shown in FIG. 28. Once securing member 762 is drawnstraight, first end 764 and second end 766 are folded to attach torespective outside surfaces of sleeve 760, as shown in FIG. 25.

In an alternate configuration, as illustrated in FIG. 29, sleeve 760 caninclude a plurality of apertures 780 on portions of intermediate portion768 that receive securing member 762 thereby allowing securing member762 to be passed through apertures 780 rather than stitched throughsleeve 760. In another embodiment, first end 764 of sleeve 760 can becoupled to second end 764 of sleeve 760 without attaching first end 764or second end 766 to the outside surface of sleeve 760. Depending uponthe particular configuration, a portion of first end 764 can overlap aportion of second end 766, or vice versa. Alternatively, first end 764and second end 766 contact each other but do not overlap. Similarly,first end 764 and second end 766 can be adjacent to one another,adjoining one another, contiguous to one another, or juxtaposed to oneanother.

To operate the restraining member or mechanism described in reference toFIGS. 26-29, a proximal end (not shown) of securing member 762 extendsto a proximal end (not shown) of guide member 712, either within orwithout a lumen of the guide member 712. Disposed upon the end ofsecuring member 762 is an actuating member, such as actuating member 20,which allows a physician or clinician to move securing member 762longitudinally to remove securing member 762 from being disposed throughat least a portion of sleeve 760. By so doing, the restraining forceapplied by sleeve 760 is released, struts 752 extend outwardly, and thefilter (not shown) is deployed.

Sleeve 760 can be formed from a variety of different materials, so longas the material is sufficiently strong to restrain one or more struts752. For example, sleeve 760 can be fabricated from various types ofpolymer or silicone films, such as but not limited to, heat shrinkplastic, polymer, low-density polyethylene (LDPE), polyethyleneterphthalate (PET), Polytetrafluoroethylene (PTFE), fluorinated ethylenepropylene (FEP), polyethylene (PE), polyurethane (PU), or siliconetubing.

Securing member 762 can be formed from a variety of different materials,so long as the material used is sufficiently strong to allow theactuating mechanisms disclosed herein to move securing member 762proximally without breaking securing member 762. For example, securingmember 762 can be fabricated from plastics, polymers, metals,composites, alloys, synthetic materials, combinations thereof, or othermaterial that is capable of performing the function of being disposedthrough sleeve 760 and capable of being withdrawn therefrom.

Referring now to FIGS. 30-34, illustrated is another alternateconfiguration of a restraining member or mechanism. This particularconfiguration utilizes a hinged configuration with a securing memberacting as the pin to maintain the hinged portions of a sleeve in aclosed configuration to constrain or restrain a portion of the guidemember.

As shown in FIG. 30, a sleeve 860 includes a plurality of channels 864a-864 f that are adapted to receive a securing member 862. Both a firstside 866 and a second side 868 of sleeve 860 are formed with some ofchannels 864 a-864 f, i.e., channels 864 a, 864 c, and 864 e on firstside 866 and channels 864 b, 864 d, and 864 f on second side 868.Through passing securing member 862 through channels 864 a-864 f insequential order, so that securing member 862 passes through a channelon first side 866 and subsequently a channel on second side 868, firstside 866 is coupled to second side 868 and sleeve 860 applies arestraining force against the struts (not shown) of a guide member.

The process of forming the restraining member or mechanism of FIG. 30 isillustrated in FIGS. 31-34. With reference first to FIG. 31, whichdepicts sleeve 860 in an open position before securing member 862 iscoupled thereto, sleeve 860 includes a number of extensions or tongues870 a-870 n. These extensions 870 a-870 n are configured to surround atubular member or tube, such as but not limited to, a guide member 812,and form channels 864 a-864 f within which securing member 862 islocated, as will be described hereinafter.

To attach sleeve 860 to guide member 812, sleeve 860 is positioned overthe desired portion of guide member 860. The securing member 862 isplaced in close proximity to guide member 860, as shown in FIGS. 31 and32. The ends of the extensions 870 a-870 n are inserted between guidemember 860 and securing member 862, as shown in FIG. 33. Alternatively,extensions 870 a-870 n can be partially wrapped around guide member 812and securing member 862 placed into contact with these partially wrappedextensions 870 a-870 n.

After the extensions 870 a-870 n are pulled tightly around guide member812 and securing member 862, an end of each extension 870 a-870 n isfolded over securing member 862 to attach to the outer surface of sleeve860, as shown in FIGS. 30 and 34. In this manner, channels 862 a-862 nare formed and sleeve 860 is configured with securing member 862 toreleasably restrain the struts (not shown) of guide member 812.

Releasing the restraining force applied by sleeve 860, alone or incombination with securing member 862, is achieved through moving orpulling securing member 862 longitudinally with respect to guide member812. The securing member 862 is withdrawn from channels 864 a-864 f toallow the biasing force of the struts (not shown) to extend the strutsoutwardly to deploy the filter (not shown). The longitudinal motion ofsecuring member 862 can be initiated through a variety of differentmechanisms as described herein, such as but not limited to actuatingassembly 20, or otherwise known to one skilled in the art in light ofthe teaching contained herein.

Referring now to FIG. 35, depicted is another embodiment of arestraining member or mechanism of the present invention. Therestraining member 960 includes a number of hoops 964 a-964 n that areadapted to receive a securing member 962. In a similar manner to thatdescribed with respect to other embodiments of the restraining member ormechanism, securing member 962 is disposed within hoops 964 a-964 n sothat restraining member 960 applies a retaining force against the strutsof a guide member 912. The securing member 962 can be removed from hoops964 a-964 n to thereby allow the struts to extend outwardly to deploythe filter (not shown). The restraining member 960 may be made frommetallic wires, polymer fibers, or other materials that can bemanipulated to form hoops through which a securing member is disposedand which can expand outwardly either under the influence of one or morestruts or due to a biasing force applied by the configuration and/ormaterial of the restraining member.

The restraining member 960 can be attached to guide member 912 and/orone or more of the struts associated therewith through variousattachment mechanisms. For instance, restraining member 960 can beattached to guide member and/or one or more of the struts throughadhesives, mechanical fasteners, securing loops, or other manner thatsecurely attaches restraining member 960 to the guide member and/or oneor more of the struts. Alternatively, restraining member 960 may beattached to securing member 962 and be removed when securing member 962is moved in a proximal direction.

Referring now to FIGS. 36-39, depicted is another embodiment of arestraining member or mechanism of the present invention. Instead of aseparate restraining member or mechanism that is connected to a guidemember, the filter media itself is adapted to function both as a filterand as a restraining member or mechanism.

As illustrated, a guide member 1010 includes a plurality of struts 1052that are adapted to extend outwardly to deploy a filter 1050 that isdisposed within a lumen 1018 of guide member 1010. The filter 1050includes two flaps 1060 and 1062 that extend between a gap 1064 betweentwo struts 1052. These flaps 1060 and 1062 are adapted to be pulledaround struts 1052 to compress them and secure filter 1050 within lumen1018, as illustrated in FIG. 37. These flaps 1060 and 1062 can beintegral with filter 1050, two separate members that are bonded orotherwise connected to filter 1050, or a single member that has anintermediate portion bonded or otherwise connected to filter 1050, withthe ends of the member forming flaps 1060 and 1062.

When flaps 1060 and 1062 have been positioned to securely retain struts1052, they are then stitched together at a location 1066 identified inFIG. 38 with an actuating member 1070. This actuating member 1070extends the length of the filter device to cooperate with an actuatingassembly, such as but not limited to an actuating assembly describedherein and those others known to one skilled in the art in light of theteaching contained herein.

Following the coupling of flaps 1060 and 1062 using actuating member1070, flaps 1060 and 1062 are folded back around the bundled struts 1052and filter 1050, and then attached to filter 1050, struts 1052, or otherportion of guide member 1012, as illustrated in FIG. 39. When actuatingmember 1070 is moved in a proximal direction, flaps 1060 and 1062 arereleased and filter 1050 is deployed as struts 1052 extend outwardly.

Although reference is made to two flaps 1060 and 1062, one skilled inthe art can appreciate that the filter can includes one or more flaps.For instance, one flap can be wrapped around struts 1052 and an end ofthe flap sewn or otherwise releasable connected to filter 1050.

Referring now to FIG. 40, depicted is another embodiment of arestraining member or mechanism of the present invention. Thisparticular configuration is depicted as part of a filter assembly 1142that can be coupled to or attached to a distal end of a guide member.The filter assembly 1142 can includes a strut assembly 1144 and a filter(not shown) coupled to strut assembly 1144. The strut assembly 1144 hasan elongated proximal end 1146 and a distal end 1148 having a pluralityof struts 1152. The length of elongated proximal end 1146 can vary basedupon the particular configuration of the guide member. For instance,proximal end 1146 can have any length greater than 1 centimeter.

As mentioned above, disposed at distal end 1148 are struts 1152. Eachstrut 1152 includes a tubular member 1154 adapted to receive a securingmember 1162. Adjacent tubular members 1154 on adjacent struts 1152 arestaggered such that when struts 1152 are brought together securingmember 1162 can be disposed through tubular members 1154 to restrainstruts 1152 and prevent them from extending outwardly, as illustrated inFIG. 41.

The securing member 1162 can extend through a lumen 1164 of strutassembly 1144 into a lumen 1118 of guide member 1112 to terminate at anactuating assembly (not shown) at a proximal end 1116 of guide member1112. Alternatively, securing member 1162 can extend through lumen 1164to exit through an aperture 1166, depicted in dotted lines, in strutassembly 1144 before terminating at an actuating assembly (not shown) ata proximal end of guide member 1112. In still another configuration,securing member 1162 can pass into lumen 1164 through aperture 1166,depicted in dotted lines, in strut assembly 1144 before terminating atan actuating assembly (not shown) at a proximal end of guide member1112.

Each tubular member 1154 coupled to struts 1152 can be fabricated from ametal, a plastic, polymer, a polymer, a synthetic materials, whether ornot the material is the same as that forming guide member 1112. In oneembodiment, each tubular member 1154 is a polymer tube, such as apolyimide or polyurethane tube that is fixed to respective struts 1152with adhesive. In another configuration, each tubular member 1154 is ametallic cut tube that may be attached to respective struts 1152 withand adhesive or solder. In still another configuration, each strut 1152includes an aperture through which securing member 1162 passes torestrain struts 1152 and prevents the same from extending outwardly.

Referring now to FIG. 42 is another configuration or embodiment of adevice according to another aspect of the present invention. As depictedin FIG. 42, a filter device 1210 includes a guide member 1212 having adistal end 1214 and a lumen 1218 extending from distal end 1214 toward aproximal end (not shown). In this particular configuration, and for easeof explanation, filter device 1210 is devoid of a restraining member ormechanism, however, in other configurations, filter device 1210 caninclude a restraining member or mechanism.

Disposed at distal end 1214 are a plurality of struts 1252, coupled towhich is a filter 1250. Although reference is made herein to struts 1252being integrally formed with guide member 1212, it can be appreciatedthat struts 1252 can be part of a strut assembly that is attached toproximal end 1214 of guide member 1212. For instance, the strutsassembly can have a proximal end that terminates substantially with aproximal end of the guide member or at a location distal to the proximalend of the guide member, whether such location is close to the distalend of the guide member or the proximal end of the guide member.

Each strut 1252 includes a distal portion 1262, a proximal portion 1266,and an intermediate portion 1264 disposed between distal portion 1262and proximal portion 1266. The struts 1252 attach to filter 1250 on theexterior of filter 1250, on the interior of filter 1250, along the edgeof filter 1250, through filter 1250, or combinations of one or more ofthe proceeding. To provide additional surface area to connect each strut1252 to filter 1250, each strut 1252 can be configured so that distalportion 1262 has a cross-sectional dimension larger than intermediateportion 1264. Stated another way, distal portion 1262 can have a largersurface area than intermediate portion 1264. The large cross-sectionalarea provided by the cross-sectional dimension of distal portion 1212provides large area for bonding each strut 1252 to filter 1250. In thisconfiguration, a strong bond is created between each strut 1252 andfilter 1250.

Similarly, each strut 1252 can be configured so that proximal portion1266 has a cross-sectional dimension larger than intermediate portion1264, while optionally having a similar, larger, or smallercross-sectional dimension than distal portion 1262. By having a largecross-sectional dimension and hence large surface area, each strut 1252can apply a greater biasing force to extend strut 1252 outwardly todeploy filter 1250.

By varying the cross-sectional dimensions of distal portion 1262,intermediate portion 1264, and/or proximal portion 1266, the degree ofbias exerted by each strut 1252 to move distal portion 1262 toward thewall of a blood vessel can be varied. The biasing force can also bechanged through optionally varying the length of each strut 1252 and/orchanging the curvature of each strut 1252.

Although reference is made herein to each strut 1252 having theabove-referenced configurations, one skilled in the art can appreciatethat one or more of struts 1252 can be configured as described above.Further, each strut 1252 can optionally be configured differently sothat each strut 1252 can have similar or dissimilar biasing forcescompared to others struts 1252 of the same filter device. Throughvarying the biasing forces, the filter device can be used for a varietyof different procedures or blood vessel configurations.

Struts 1252 can be formed from Nitinol, stainless steel, metals, alloys,composites, plastics, polymers, synthetic materials, or combinationsthereof. Each strut 1252 can have a generally curved distal portion1262, proximal portion 1266, and/or intermediate portion 1264.

Disposed with lumen 1218 at distal end 1214 is a core 1260 forming partof an atraumatic tip 1262. Surrounding at least a portion of core 1260is a coil 1264 that provides flexibility and radiopaque properties toatraumatic tip 1262. The core 1260 passes through an aperture 1266 in adistal end of filter 1250. Alternatively, core 1260 passes through oneor more pores formed in filter 1250.

To secure filter 1250 to atraumatic tip 1262, a securing coil 1270surrounds a portion of coil 1264 and the distal end of filter 1250.Although this is one manner to connect filter 1250 to atraumatic tip1262, one skilled in the art can identify various other manners toconnect filter 1250 to atraumatic tip 1262. For instance, the distal endof filter 1250 can be bonded to atraumatic tip 1262 using adhesives,mechanical fasteners, crimping, seals, friction fit, press fit, or othermanners to connect filter 1250 to atraumatic tip 1262. In anotherconfiguration, filter 1250 is not connected to atraumatic tip 1262 butcan slide along a portion of atraumatic tip 1262.

Referring now to FIG. 43, another illustrative embodiment of the presentinvention is depicted. The majority of the features previously discussedwith respect to other embodiments of the present invention apply to thisexemplary embodiment.

A filter assembly 1342 comprises a filter 1350 and a spring member 1364.Filter 1350 includes a plurality of struts 1352. These struts 1352 arelengthened strands of filter 1350. These struts 1352 connect filter 1350to actuating member 1340 and are unbiased. Alternatively, struts 1352can be biased to open filter 1350.

Disposed at proximal end 1358 of filter 1350, is biased spring member1364. Biased spring member 1364 has a coil-type configuration andincludes a proximal end 1368 that extends into lumen 1318 of guidemember 1312 to be attached to actuating member 1340, such as similar toactuating member 40 discussed herein, and/or a head 1344. Spring member1364 is biased to an opened position where spring member 1364 formsopening 1360. During deployment of filter assembly 1342, the flow ofblood through the blood vessel applies a force to filter 1350. Thisforce enables filter 1350 to be withdrawn from lumen 1318 and becomedeployed into the form described herein. Since spring member 1364 isbiased to open, spring member 1364 draws the outer peripheral edge offilter 1350 at proximal end 1358 toward the inner wall of the bloodvessel.

To retract filter 1350, actuating member 1340 is moved in the proximaldirection, causing proximal end 1358 of filter 1350 to be drawnproximally. This causes proximal end 1358 to be drawn toward lumen 1318and become closed, thereby enabling filter 1350 to be removed throughthe procedure discussed herein, such as through use of a capturecatheter.

Various configurations of capture catheter are known to those skilled inthe art in light of the teaching contained herein. The capture cathetersdescribed herein can be used with any of the embodiments of the filterdevice or guide member described herein.

As illustrated in FIG. 44 an alternate embodiment of a capture catheter,designated by reference number 1390 is illustrated. As shown, capturecatheter 1390 includes a distal portion 1392 and a positioning member1394 connected or attached to distal portion 1392. The distal portion1392 includes a lumen 1400 extending from a distal end 1396 to terminateat an aperture 1402 at a proximal end 1398 thereof. The distal end 1396optionally includes a radiopaque marker or band 1408, while lumen 1400is configured to receive a filter assembly of a filter device in asimilar manner to lumen 92 of capture catheter 90. Alternatively, lumen1400 can include a stop member 1404, depicted in dotted lines, with ahole 1406 therethrough. The stop member 1404 allows guide member 1412 topass through hole 1406, but prevents a filter assembly disposed at adistal end of guide member 1412 to pass through hole 1406 once capturecatheter 1390 has received the filter assembly within lumen 1400. Oneskilled in the art can identify various other configurations of stopmember. For instance, hole 1406 can be disposed in stop member 1404 atany location.

To move capture catheter 1390 along guide member 1412 of the filterdevice, capture catheter 1390 includes positioning member 1394. Thispositioning member 1394 has sufficient stiffness that application of aforce at a proximal end 1416 can be transferred to longitudinal motionof distal portion 1392 of capture catheter 1390. In one configuration,positioning member 1394 is a solid member, while in anotherconfiguration positioning member 1394 is hollow or has at least aportion thereof hollow. The positioning member 1394 can be fabricatedfrom a polymer, a plastic, polymer, a synthetic material, a metal, analloy, combinations thereof, or other material that can be used formedical devices and has the needed stiffness.

As illustrated in FIG. 45 an alternate embodiment of a capture catheter,designated by reference number 1420 is illustrated. As shown, capturecatheter 1420 includes a distal end 1422 and a lumen 1424 extending fromdistal end 1422 to terminate at an aperture 1426 at a location proximalto distal end 1422. Lumen 1424 is configured to receive a filterassembly of a filter device in a similar manner to lumen 92 of capturecatheter 90, while aperture 1426 is adapted to receive guide member 1412and prevent passage of filter assembly of the filter device. In thisconfiguration, the length of lumen 1424 is configured to prevent capturecatheter 1420 from being advanced further over the filter device orfilter assembly of the filter device than is required. Alternatively,lumen 1424 can include a stop member similar to stop member 1404discussed herein. Furthermore, capture catheter 1420 can optionallyinclude one or more radiopaque markers disposed at and/or between adistal end and a proximal end thereof.

Referring now to FIG. 46, depicted is another embodiment of a capturecatheter in accordance with another aspect of the present invention. Asillustrated, capture catheter 1490 is adapted to cooperate with a filterdevice 1510. The illustrative filter device 1510 includes a filterassembly 1542 coupled to a distal end 1514 of guide member 1512. Thefilter assembly 1542 includes a plurality of struts 1552 and a filterconnected to one or more of the plurality of struts 1552. As shown,filter assembly 1542 is a separate component that is attached,connected, or coupled to guide member 1512. In an alternateconfiguration, however, filter assembly 1542 can be integrally formedwith guide member 1512, such that each of the plurality of struts 1552is formed from a portion of guide member 1512. Also forming part offilter assembly 1542 is an atraumatic tip 1560. This atraumatic tip 1560can be disposed through filter 1550 of filter assembly 1542.Alternatively, atraumatic tip 1560 can pass around filter 1550, asdepicted in dotted lines, and be configured from one of the plurality ofstruts 1552 that elongated.

Returning to capture catheter 1490, the capture catheter 1490 includes adistal portion 1492 and a proximal portion 1494 that communicates withthe distal portion 1492. The proximal portion 1494 is stiffer than thedistal portion 1492 and can have a similar configuration to the othercapture catheters described herein. For instance, proximal portion 1494can be capture catheter 90, can have a similar configuration to distalportion 1392 of capture catheter 1390, or can be capture catheter 1420.The distal portion 1492 is flexible and tapers from proximal to proximalportion 1494 to a distal end 1498 of capture catheter 1490.

Disposed at distal end 1498 is a lumen 1500 that receives guide member1512 of filter device 1510. Lumen 1500 can be formed from a separatetubular member that is connected, attached, or coupled to the distal endof capture catheter 1490. Alternatively, lumen 1500 can be formed fromthe distal portion 1492 of capture catheter 1490. The lumen 1500 isadapted to slidably receive guide member 1512 of filter device 1510, butprevent passage of filter assembly 1542. Stated another way, filterassembly 1542 has an outer diameter greater than the inner diameter oflumen 1500. Consequently, as capture catheter 1490 is moved in a distaldirection, distal end 1498 engages with either a proximal end of filterassembly 1542 or one or more of the extending struts 1552. As capturecatheter 1490 continues to be advanced, distal portion 1492, due to itsflexibility, begins to invert, as depicted in FIG. 47. As capturecatheter 1490 is continued to be advanced, struts 1552 and filter 1550are completely enclosed within capture catheter 1490, as shown in FIG.48.

Embodiments of the present invention and the various components orelements thereof can be used interchangeably so that features andfunctions of one exemplary embodiment of a filter device can be usedwith other embodiments of the filter device. Illustratively, therestraining members or mechanisms of the described embodiments of thepresent invention can be used with multiple different configurations ofthe filter device. Further, exemplary capture catheters can be usedinterchangeably such that any capture catheter can be used with any ofthe described filter devices and such other that may be known to thoseskilled in the art in light of the teaching contained herein.Additionally, methods of using one embodiment of the present inventioncan be used with other embodiments of the present invention. Therefore,embodiments of the present invention provide filter devices that havesmall, low, or no profiles, few parts and components, are simple tomanufacture and use, are able to be easily inserted into a patient, besteerable through the tortuous anatomy of a patient, provide filteringcapabilities, provide exchange capability so other medical devices canbe advanced over or along the filter device, and be capable of removingcaptured material without allowing such material to escape during filterretrieval.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1. A restraining mechanism configured to prevent a plurality of strutsof a filter device from extending outwardly prior to deploying a filterof the filter device, the restraining mechanism comprising: (a) a sleeveadapted to be disposed substantially at a distal end of the filterdevice, said sleeve being adapted to apply a restraining force to theplurality of struts of the filter device to prevent the plurality ofstruts from extending outwardly; and (b) at least one actuating membercoupled to said sleeve, said at least one actuating member being adaptedto release said restraining force of said sleeve and enable theplurality of struts of the filter device to extend outwardly.